biostudies-literatureBernhardt JStroke AssociationNational Institute for Health Research (NIHR)e008378https://www.ebi.ac.uk/biostudies/studies/S-EPMC4550737biostudies-literatureUnknown5(8)<h4>Objective</h4>The purpose of this paper is to examine potential threats to generalisability of the results of a multicentre randomised controlled trial using data from A Very Early Rehabilitation Trial (AVERT).<h4>Design</h4>AVERT is a prospective, parallel group, assessor-blinded randomised clinical trial. This paper presents data assessing the generalisability of AVERT.<h4>Setting</h4>Acute stroke units at 44 hospitals in 8 countries.<h4>Participants</h4>The first 20,000 patients screened for AVERT, of whom 1158 were recruited and randomised.<h4>Model</h4>We use the Proximal Similarity Model, which considers the person, place, and setting and practice, as a framework for considering generalisability. As well as comparing the recruited patients with the target population, we also performed an exploratory analysis of the demographic, clinical, site and process factors associated with recruitment.<h4>Results</h4>The demographics and stroke characteristics of the included patients in the trial were broadly similar to population-based norms, with the exception that AVERT had a greater proportion of men. The most common reason for non-recruitment was late arrival to hospital (ie, >24 h). Overall, being older and female reduced the odds of recruitment to the trial. More women than men were excluded for most of the reasons, including refusal. The odds of exclusion due to early deterioration were particularly high for those with severe stroke (OR=10.4, p<0.001, 95% CI 9.27 to 11.65).<h4>Conclusions</h4>A model which explores person, place, and setting and practice factors can provide important information about the external validity of a trial, and could be applied to other clinical trials.<h4>Trial registration number</h4>Australian New Zealand Clinical Trials Registry (ACTRN12606000185561) and Clinicaltrials.gov (NCT01846247).BMJ openExploring threats to generalisability in a large international rehabilitation trial (AVERT).PMC455073712/01/16TSA2009/09Patton SAllison JVile MBoggs AMortimore JMullan DHalliday JO'Hare LLane EWhitelaw MHalliday PPetrolo SKlose ETharakan SSeymour KWong PHAttard LTrippier SWan Nafisah WYLazaridou MRussell TSundararajan LBailey JTimms TToombs KMcRae AKryszkowska MHoward JSummers JMcCulloch JHutchinson KNewell JWilliams-Yesson BWhite RThrift ABenham DYeap SWaite AMacleod MHutchinson TLieschke ATougher BGillespie SWhite CHolman DHamson EChoo SJanssen HMead GCassels-Brown KTeo IMaher EBrewer TMead NRagonton ETinsley MLee CKKeeling MJose SReilly RKaur HGething SEdmonds GIndredavik BWest TKeeling EEastwood DFeatherstone JLatif RMcGrath RO'Reilly CSturm JNunlist NMills DSaunders KDeutsch AGalang LBoyd MMurray AHand PMcDowell MO'Donohue LPrescott MTse CChen RBurke KMurtagh EKennedy ANelson EKennedy MNelson RSomaratne SChen CNelson KBath PMcGhee CBode LAtkinson PBoyle RBoyle SArriagada JMartin-Francisco JO'Reilly JRogan EDoughty MChamberlain JJohnson NFawcett MWhyatt CPurves MCowmeadow JGow HQuick KAdedoyin TCrawshaw NMurphy PJacobsen AMurphy NMurphy MNinhadi SHHalpin MMcCluskey AAnderson AGates PMartin DAhern EMcAuley SMacartney DMcConnell LAnderson LHibbert EWalch KHumphrey RClatworthy KHecita DVahidassr JMaclagan ACooke SDuffy MVillaluz CWalters MCassidy PHeaney DPenero VBaxter MBaxter LCrabbe DHunter HHutton JQuiney JKramer SHankey GWills APeterson FLyons LKatijjahbe MAByrne KZebedee JAzmi MIOrpen APushpa-Rajah JByrne BDevoy IFrame KRodway KMoye JPollock AMason KPurvis TLapsley KThomas GLegg LPaton ALock KLennon SGadhvi CRiley VCousins KThomas MShaw SKent FCuthill LDavison RCramb JMcParland MRavinder KBRosnita KField MBlack JLouis RClarke KCox JColquhoun EKurian JHaidar OClarke CCox SSampson JByrnes WGendre CWoolstencroft RBaker RKok JPearson TTan CKRichards KClarke REnomoto MMcCagherty Evan Vliet PLeong ECormack LMcGinley PMarcus RChand KGreig JKatalinic ODouglass DErrey RMoloney KScanlan CBilston SGreening EBates CWilding PPathirage MMackenzie MHarvey DLacey AWavish GFarrell JTighe LVickers CKarageorge SHarrison ASteele ASavickas SNorman TPachett RLeal LMcCracken SBronca MArmit HGissane SAnnamalai ATwist LCrow JBerney SGan NPalfreeman HGordon CThilarajah SEsson DOliver MStilwell JBeale LNair APavanni RFaizal MStrong RMcWhinney RGomez CMcNally CJames DTaylor RParsons BGonzalez RParsons CWright STaylor LJoyson AJames MOtto RTaylor GKwan JMashitoh KMDifuntorum ETay-Teo KQuah DBaird KDuncan RJohn AWroath BMoseley SVelupillai GSpear MHowells DCraig KHammonds FCraig LWatkins JJeffs CNorliza IMorrison JSilva GAdair PWiggam IMorrison RDickson CMarsh EHellier KFrayne JMacleod MJMawson CCowie HUgalde MNicol MJones EBrice VNicol KHarshaw SLanes JWhiteman SRoy SStyles GSamakowidic TIzuani MGeorge STerry TStyles JGillett SGreen AHuggins KGreen EGreen HCic PSnowball LGermaine JFergus PGreen NWorboys HPlant EGreen VCamilleri BTait LLouw SSachs TBagot PAncliffe JThompson CSaleh KMokoena LMizen JThompson AAmes DQiu NMcIntyre TALack HInal MEfri MHFitzgerald CHill APeters KTampiyappa AHunt GHunt JFitzgerald JWilkinson BRedpath LGibbins CDawson MLi CNaismith CMitchelson KGuest KKilbride GDonnan GFrancis JLeavold FJones NTorrens JThrift AGBuck KBrand LFadilah AZLerner SScott EBurrow RSaid CWallace JDewey HMZunaidah ASGasior MHolgate KScott NAitchison OLaverde MScott JDickie CMarr LSkinner AScutcheon DMontague LScott SGangi SDonnan KCrossland SSheldon VHendrie DEdirimanna NTan HJJackson NJackson SWharrie RCollins RHodkin RTing LMarr ERedpath AMorris TZhang WThompson SMoss EWorton RDulleh MPorter JAshburn ACollins MTraumanis MYin LCollins KThompson TPlumb SLanghorne PShelley JMinett MManak BWilson JO'Brien BWilson NBakshi MMartial BLowndes SRitchie CTalbot LChalmers AGallaher TRohaizah RMoody MConnor SO'Brien PHayward DTria YMan ZCPeace BKerr GWijeratne TWeaver DKane TPei Pei TMajcher KHayward LMain LChong VChoat STomlinson RButton COrefo CCourtney APearce JAshoka SLagerstedt TDescallar RGibbs JHairsine BRosbergen IRodger CMcKay KBuchanan KHameed SJacobs MMcKay EPugh CWong WPElder-Gracie TBoreham JSafwan JHirst KNall CDowney NMcDowall KFollent SUsher DButler DButler ESymington MMcPherson GRichard BSaitamis HSimpson TRiddell VVu TKopelke KAustin NTrinh KBatcheler SMcKellar DKilley BHoward SAStanwell LHau LCarroll CBrown DWeston SBrown CAshton KTooth MYasue TWatchurst CPain SGraham FWade SFay POcchiodoro TTan DDane GBowring AThackeray MHaritos NDwyer IVardy AGraham JDoran BDuff NSpehr JHindson MYang SStansfeld KJoseph SPower MOvington CEllery FPower HTecle RKipps SFeely EDyke MMeakin PDickinson CBallinger KPower AAllport LSim ENg KAVERT Trialists’ CollaborationRobinson KSharifah SMMorgan HComiskey LMorgan CWhatley EYawieriin RSmallwood CNand KLWinter EBrown PBladin CDeVries NNunn CHills TLam RTay PYMorgan RBarkhuizen WWilliamson HCSimons CProudfoot FMill CMountford HYoung DArmstrong KArmstrong JBeckwith TCamac MDenton TWiesner KBurgess SForsyth SKerin LArmstrong BDouglas CBurrows JSequeira MVan Holsteyn JDonnan GABorschmann KBurgess FCageao JWalker KBroadhead KLoege ANewton GHeath MMcLeod PWalker LXu PWilliamson SWalker SMcFadyen AHawkins AWiseman EHeath SFisher MSanders LStorey KLevy RKemp JYoung JMiller LWillems SMai TRhodes LYee YLAhmad MTMiller SMoodie MFok AShahrul IHendley NSims MRappeport BBritto JRitchie MWLongland BMcKenna SSpeare SChiu MMaltman LFriend MDunne AKinniburgh MRebis MRodgers HMcKenna BPickup AHeard TKruger KCoates TReader MShlanski AAuld GArmstrong SHong SArmitage LRoberts SHussien HDavis SAndersen PKalinowski SDavis MGoddard HChurilov LReynolds JLacivita JGalbraith PGilbert SJones SAReynolds GCarter RAng CWalton NFries LGilbert CHyde ATroake JMcritchie SWoolley DHaber ADevi Thapa TBall GMcEneaney ESpry SMcKimmie MBrowne PGriffiths LStevens STombe SBrowne CAi Sing GMcNamee MOhlback SBeranova EBanks CGavin JBurgess AOng GSmyth MBennett CHerzig MYorston PHarris ZBennett KDewey HCumming TBoxall LGriffiths AWalshe RRevell EHarris AStevens BBennett SStevens COng MChristin PAbeykoon EStepan FMunro MHarris GTeoh ZGriffiths DHarris KEaso Svan Bysterveldt ENunan LPomfret SStreet SLacy MJa'afar JTauro SKleine APage KPage JTrinder JOwen KMan Ying CRay EMcKearney HFuertez DDass SKalubowilage PCurchin SNeal DLloyd NDyer NSertori SWeir LGerraty RBryce ARyan JMcLennan SBrakey ATiliacos NShannon MLloyd DBracher SMoorhead HKohler SFaulkner MNicholas ZBooth NShannon CMagandi SMcGuiness MLaurenson JMcDonough NCoulter EBakari MFMandri CKeo LBryant MWood DWood CMurdy JHowes RKendal NFulgencio CRoberts LRoberts KFarquhar MLindley RLindquist SAzlina AKinnaird MShrimpton JMackay JBarkat AO'Neill TSirgo BMacDonald SWatson FWatson AMiddleton SSingh RMacDonald HSmee SNicholson CBertulfo MLogan NDow JMaurenbrecher LSmart SJeyaraj NPombuena MTraynor ALakey RBehanan SJamieson NLlenes RWhisson SSmart ADevlin CStepney ADevin RWesseldine ABray LBarrett CRead SSlow JGunathilagan GChen JJMillar MAlexander JNeilson DErnst KMcCormack DLogan SCrook GSta Maria NMcCallum KFerris MNim PNorth MHakim EHorvath FSmith DBeggs ELawrence JSmith ASmith HSmith LAbela CMaccanti HGrant CSmith NSmith MSmith SSmith RMcCord KSheppard LBlair TDelrosario-Kelly DFathuddeen HLord JWarwick AHlaing MMacdonell AMackey LRobb AWilliams FMcAllister AMagnall BMatlioski JPatel HVerral TCrawford SCollier JDiwakar PDixon MGawned SCloud GKingwell HKat KBendix EPatel VGilligan LCroft JSamadi NSahathevan RHalkett MGibson MGibson LWilliams VLawless KCharnley CScrivener BBuckley EHare CDela Costa MBuckley CKwant JHamilton LVarendorff SSeow HCKelly CRaffelt AMcMahon MRatnagopal PRoughan CMathew TOlenka LZhao HMathew SLangdon SCrosby VFogliani PNewth MGiofre NRobles BWall KLuker JKoltermann JDongre RNoor Azah ACohen BHewat SMerheb RBabenschneider CMcConville CFatchen NTilley VTilley SBillinger MHochmuth KGill CDe Rivera KMcDonald NNoonan LArcher CTilley JMelling RBalfour DDayal NKar ADaniel NParker JDaniel AForshaw DNoonan ADurdu HLuscombe AFichera DLindley RIBainbridge KLee YFNesbitt AOermann BMcGeown RBernhardt JBacon SLy NLim PPolmear LAird LLim RBurke MJMcArdle FHewett AWeadon JLebeter SIrvine JDiocera DSangvatanakul PNayWin CCoyle JCarswell CKoh GWalsh SBlundell ENanthakumar SBritton JRahim NFairbrother MBell CHann GHart SBell JMcGavin KBell IReid NRobertson AAskim TGellie GAugoustakis LMoore LRobertson JClanachan CGhatala RMoore AReid CHozack KReid EFurnace JJoyce SHughes NBlacker DHughes MMacvicar ABruce MKe ZColeman VMartin MCaspers KMcAuley CRichardson ROdelli RKeenan SRathnayake NKavalieros PWheelwright DJackaman VMatthews MHughes ABoard SRichardson JGroot PRichardson KPorteous MHenderson JDuguid CFearson LHegarty LConrad JMcCarthy ELim GMLee SWhittaker FTyers ARodda LAdrian JLee JVernon CLee HLee BPowell GCheng TAckroyd LEdwards AKirk SHarvey-Fitzgerald LEdwards CNorlinah MIBaston DWerner LHolland JCassama VPrice LAu EGupwell KHolland DAdams RAdams PMohanraj RBrunt HAllen SSheedy RPrice CBramah VQin CAllen TFord JWu OBarber ELambert ECornwall LEveritt KBarber MNolan GBrotheridge SBindra JBrady RGrimley RHogg VGilpin SWang VBerry SBurt JHogg LIgnatius NRees VFoster WLinden TGilpin JGarcia-Vega MHope SAppleby SChurch JMcCallion CHope EMcGoldrick CMcGlone CPrasad ABarber ARozita APesavento LMolan VProud LSherry LDoolan RStorey GRogers THaughey JHerman JWilliamson HCoghill SSrikanth VRogers SShakir IMorey DRogers HFong FKRogers EBanerjee SHeckenberg KCameron WForman CRowley DStudden NPowles KPyke MApirutvorrachod WCameron JHaryani HSawers MQuang LCMaclean MAnos FCobani VMcAtamney AZaharah MAfalseExploring threats to generalisability in a large international rehabilitation trial (AVERT).<h4>Objective</h4>The purpose of this paper is to examine potential threats to generalisability of the results of a multicentre randomised controlled trial using data from A Very Early Rehabilitation Trial (AVERT).<h4>Design</h4>AVERT is a prospective, parallel group, assessor-blinded randomised clinical trial. This paper presents data assessing the generalisability of AVERT.<h4>Setting</h4>Acute stroke units at 44 hospitals in 8 countries.<h4>Participants</h4>The first 20,000 patients screened for AVERT, of whom 1158 were recruited and randomised.<h4>Model</h4>We use the Proximal Similarity Model, which considers the person, place, and setting and practice, as a framework for considering generalisability. As well as comparing the recruited patients with the target population, we also performed an exploratory analysis of the demographic, clinical, site and process factors associated with recruitment.<h4>Results</h4>The demographics and stroke characteristics of the included patients in the trial were broadly similar to population-based norms, with the exception that AVERT had a greater proportion of men. The most common reason for non-recruitment was late arrival to hospital (ie, >24 h). Overall, being older and female reduced the odds of recruitment to the trial. More women than men were excluded for most of the reasons, including refusal. The odds of exclusion due to early deterioration were particularly high for those with severe stroke (OR=10.4, p<0.001, 95% CI 9.27 to 11.65).<h4>Conclusions</h4>A model which explores person, place, and setting and practice factors can provide important information about the external validity of a trial, and could be applied to other clinical trials.<h4>Trial registration number</h4>Australian New Zealand Clinical Trials Registry (ACTRN12606000185561) and Clinicaltrials.gov (NCT01846247).2015-01-01T00:00:00Z2015 Aug2024-11-07T04:59:44.387Z2019-03-26T22:45:57ZS-EPMC45507372628366710.1136/bmjopen-2015-008378